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Effects of Textured Insoles on Balance, Physical Performance, and Plantar Pressure in Older Adults With Knee Osteoarthritis

NCT ID: NCT07097649

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-10-01

Brief Summary

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This study aims to investigate the effects of textured insoles on balance, physical performance, and plantar pressure distribution in older adults with medial compartment knee osteoarthritis. Participants will be randomly assigned to two groups: the intervention group will receive textured insoles, while the control group will receive flat insoles without texture. Both groups will use their respective insoles for 4 weeks in their daily life. The study includes pre- and post-intervention assessments using balance platforms, functional performance tests (such as the Timed Up and Go, 30-second Chair Stand Test, and Step Test), and plantar pressure analysis. This randomized controlled study is designed to evaluate the effectiveness of textured insoles as a non-invasive and easily applicable rehabilitation method in improving balance and pressure distribution in elderly individuals with knee osteoarthritis.

Detailed Description

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This randomized controlled trial will include older adults aged 65 and over who have been diagnosed with medial compartment knee osteoarthritis according to the American College of Rheumatology criteria and have radiological evidence (Kellgren-Lawrence grade 2 or 3).

Eligible participants will be randomly assigned into two groups: a textured insole group and a flat insole group. Participants will wear the insoles in their daily footwear for a period of 4 weeks.

Baseline and follow-up assessments will include:

* Static and dynamic plantar pressure distribution using the Diasu® baropodometric system.
* Balance assessment using the HUR Smart Balance platform under four conditions (eyes open, eyes closed, eyes open on unstable surface, eyes closed on unstable surface).
* Functional performance tests: Timed Up and Go (TUG), 30-second Chair Stand Test, and Step Test.
* Disease-specific questionnaires: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).
* Q-angle and knee proprioception measurement. Data will be analyzed to determine whether the use of textured insoles improves balance, physical performance, and plantar pressure distribution more effectively than flat insoles in older individuals with knee osteoarthritis.

Conditions

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Knee Osteoarthritis

Keywords

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Medial Compartment Knee Osteoarthritis Textured Insoles Balance Plantar Pressure Physical Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into two parallel arms: the intervention group will receive textured lateral wedge insoles, and the control group will receive flat lateral wedge insoles without texture.

Both groups will wear the insoles in their daily footwear for 4 weeks. All participants will be assessed using standardized protocols covering balance, plantar pressure distribution, physical performance, and biomechanical parameters, through objective measurement systems.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No parties were masked due to the nature of the intervention.

Study Groups

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Textured insoles group

Participants will use textured insoles for 8 weeks.

Group Type EXPERIMENTAL

Textured lateral wedge insole

Intervention Type DEVICE

Participants in the experimental group will wear custom-designed textured lateral wedge insoles made from EVA material. These insoles incorporate lateral wedging to offload the medial knee compartment and a textured surface to enhance plantar sensory input. Participants will use the insoles during daily activities for a period of 8 weeks, with no additional intervention or exercise protocol.

Lateral wedge flat insoles group

The researchers will use flat insoles with lateral wedges for 8 weeks.

Group Type ACTIVE_COMPARATOR

Use of lateral wedge flat insole

Intervention Type DEVICE

Participants in this arm will use a customized lateral wedge flat insole with the same lateral inclination as the experimental insole but without any textured surface. This design allows for controlling the mechanical effect of the wedge while eliminating additional sensory stimulation.

Interventions

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Textured lateral wedge insole

Participants in the experimental group will wear custom-designed textured lateral wedge insoles made from EVA material. These insoles incorporate lateral wedging to offload the medial knee compartment and a textured surface to enhance plantar sensory input. Participants will use the insoles during daily activities for a period of 8 weeks, with no additional intervention or exercise protocol.

Intervention Type DEVICE

Use of lateral wedge flat insole

Participants in this arm will use a customized lateral wedge flat insole with the same lateral inclination as the experimental insole but without any textured surface. This design allows for controlling the mechanical effect of the wedge while eliminating additional sensory stimulation.

Intervention Type DEVICE

Other Intervention Names

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Lateral wedge textured insole

Eligibility Criteria

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Inclusion Criteria

* Aged between 65 and 75 years
* Diagnosed with medial compartment knee osteoarthritis
* Able to walk independently without assistive devices
* Having foot size compatible with available insole sizes
* Volunteering to participate in the study and providing informed consent

Exclusion Criteria

* Diagnosed with neurological diseases (e.g., stroke, Parkinson's disease, multiple sclerosis)
* Diagnosed with vestibular disorders or balance problems due to inner ear issues
* Having a history of lower extremity surgery in the past year
* Severe foot deformity that prevents insole use
* Having visual impairment that is not corrected with glasses
* Currently using a walking aid (cane, walker, etc.)
* Cognitive impairment or inability to follow instructions
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Esra Nur Turkmen

OTHER

Sponsor Role lead

Responsible Party

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Esra Nur Turkmen

PhD Lecturer, Principal Investigator - Department of Physiotherapy and Rehabilitation, KSÜ

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Esra Nur Türkmen, PT, PhD

Role: CONTACT

Phone: +90 554 523 98 30

Email: [email protected]

Study Documents

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Document Type: Clinical Study Report

View Document

Other Identifiers

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LHU-TEXTINSOLE-2025-01

Identifier Type: -

Identifier Source: org_study_id